Roadmap toward a strengthened national Pharmacovigilance … · 2020. 11. 9. · Improving the...

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Roadmap toward a strengthened national

Pharmacovigilance system in

Ethiopia, for a Period of Five Years

July 2020

A.A, Ethiopia

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Preface

Worldwide, numerous numbers of drugs are released into the market every day with

incomplete information about their safety on larger and diversified populations raising

concern on their safety. This calls upon strengthening pharmacovigilance system. It is also a

common practice of public health programs to make use of Mass drug and vaccine

administration. The large number of populations receiving these drugs may come up with

harm if not monitored properly. This has given an opportunity to develop systems for

generating valid data that will contribute to informed decision making.

The development of this national roadmap is a reflection of implementation of the core

initiatives within the county’s health sector transformation plan that strategizes to improve

the Regulatory system through pharmacovigilance. It has also comprehended the links with

the drug safety monitoring strategies of public health programs.

This national pharmacovigilance road map of Ethiopia for 2019-2023; expresses the

continued commitment of the national drug regulatory Authority and the Federal Ministry of

Health towards the attainment of the overarching goal of having a matured

Pharmacovigilance system.

Finally, the National Regulatory Authority calls upon all stakeholders working in the area of

Pharmacovigilance to use this national roadmap as our common guiding reference for our

operations, to take improved actions and commitment to bring prompt change in reducing

medicines related harm.

HeranGerba

Director General,Ethiopian Food and Drug Authority,

Ethiopian Food and Drug Authority

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List of abbreviations/Acronyms

ADR Adverse drug reaction

ADE

AEFI

AHRI

aDSM

CDT-Africa

Adverse drug event

Adverse Event Following Immunization

Armauer Hansen Research Institute

Active Drug Safety Monitoring

Center for Innovative Drug Development and Therapeutics trials for

Africa

DAC

DIC

Drug Advisory Committee

Drug Information Center

DTC Drug and Therapeutics Committee

EAC East African Community

EFDA Ethiopian Food and Medicine Authority

EPI Expanded Programme on Immunization

HCP

HSTP

Health-Care Professionals

Health Sector Transformation Plan

ICSR Individual Case Safety Report

MAH

MOH

Marketing Authorization Holder

Ministry Of Health

NEPAD New Partnership for Africa’s Development - agency

NTD

NTP

Neglected Tropical Diseases

National TB Program

PASS Post Authorization Safety Study

PAVIA Pharmacovigilance Africa

PHP Public Health Programme

PROFORMA Pharmacovigilance infrastructure and post-marketing surveillance

system capacity building for regional regulatory harmonization in

East Africa

PSUR Periodic Safety Update Report

PV Pharmacovigilance

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QPPV Qualified Person for Pharmacovigilance

RMP Risk Management Plan

SAE

SOP

Serious Adverse Event

Standard Operating Procedure

TB Tuberculosis

ToR Terms of Reference

UMC Uppsala Monitoring Centre

WHO World Health Organisation

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Table of contents

Preface 2

List of abbreviations/Acronyms 3

Table of contents 5

1. Background and justification 6

1.1. Pharmacovigilance in Ethiopia 6

1.2. Significance of the Road Map 6

1.2.1. Brief description of the roadmap development process 6

1.2.2. Overview of key gaps identified from the baseline situational analysis 7

1.3 Alignment of this roadmap with existing national strategic plans 9

2. Goals and strategic objectives of this roadmap 10

3. Methodology and team 10

3.1. Developing the roadmap 10

3.2. Relationship between this roadmap and the annual work plans 11

4. Key milestones and activities per strategic area 12

4.1. Improving the efficiency and functioning of regulatory and organizational structures 12

4.2. Improving the financial sustainability of PV activities in the country 13

4.3. Clarifying the roles and responsibilities for all stakeholders towards ensuring the safety ofmedicines 13

4.4. Increasing the effectiveness of active (sentinel) surveillance of ADRs 13

4.5. Improving connectivity of databases and (use of) tooling for event detection, reporting,analysis and dissemination to relevant stakeholder 14

4.6. Increasing human resources to sufficiently exercise safety-monitoring activities throughoutthe country 14

4.7. Improving PV-relevant skills and competencies at various levels 14

4.8. Gaining experience in monitoring and steering the performance of the PV system 15

4.9. Better align with regional and international initiatives to avoid fragmentation of resources &investments 15

Table. 1. Activity Plan 16

Activities regarding aDSM 32

Activities Regarding EPI and NTD Program 35

5. Conclusion 38

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1. Background and justification

1.1. Pharmacovigilance in Ethiopia

The World Health Organization (WHO) has defined PV as “the science and activities relating

to the detection, assessment, understanding, and prevention of adverse effects or any other

possible drug-related problems.”1 The aim of the PV system is to protect the public from

medicines-related harm. Currently few low- and middle-income countries have a well-

functioning PV system to support the timely identification, collection, and assessment of

medicine-related adverse events.

Ethiopia established its national PV system under Food, Medicines and Healthcare

Administration and Control Authority (FMHACA) in 2002. In 2009 Ethiopia became a full

member of the WHO Program for International Drug Monitoring. The number of adverse

drug reaction (ADR) reports received from healthcare providers to the national centre have

been limited.

Voluntary reporting has come into effect as of 2002 through the activities performed by the

Adverse Drug Reaction Monitoring Division of the Drug Administration and Control

Authority. A simple reporting form was developed and made available throughout all the

health facilities. Various trainings were given, and face-to-face discussions about adverse

drug reaction/events monitoring were also performed. In spite of these activities, still there

remain important interventions to be implemented to strengthen the existing system and

infrastructure, in monitoring ADR and reduce related harms in the public.

1.2. Significance of the Road Map

1.2.1. Brief description of the roadmap development processThis roadmap was developed based on a baseline situational analysis on the strength and gaps

of pharmacovigilance system of Ethiopia performed by PAVIA and PROFORMA projects.

Based on the gaps and challenges identified during the baseline situational analysis a

workshop with all key stakeholders in the country was held to discuss the findings and define

the desired ‘end state’ for the PV situation of the country. This roadmap has been developed

1WHO 2009, The importance of pharmacovigilance. Safety monitoring of medicinal products. Geneva.

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through stakeholders’ engagement involving baseline assessment, subsequent stakeholders’

workshop and consultations.

This roadmap outlines the areas for PV strengthening, with key activities. Detailed activities

are laid down in the subsequent annual work plans.

1.2.2. Overview of key gaps identified from the baseline situational analysis

Resources at the PV centre are inadequate for the full implementation of provisions in the

2014 Guidelines for Adverse Events Monitoring. The annual budget of EFDA has no

earmarked budget for the PV function which hinders, its management to plan properly for

sustainability and long-term development.

EFDA would need to establish a PV inspectorate to ensure that stakeholders e.g. MAH

are following the reporting requirements mentioned in the guidelines.

Although the staff members of the PV centre are experienced and well trained, given the

large population size of Ethiopia, they are too few to promote PV and engage all

stakeholders such as healthcare organizations, healthcare professionals, Marketing

Authorization Holders, Academia, Public Health Programmes, media and the public at

large. The input of reports of suspected medicine related harm received from these

stakeholders is far too low, leading to very limited output and results from the system.

Currently, there is no specific PV advisory committee. The Drug Advisory Committee

(DAC) / AEFI committee is used to serve as such but may not consider all PV issues.

Thus, there is a need to establish a formal PV Advisory Committee and provide the

required training to members of the committee.

The inadequate input of observations of suspected harm to the system leads to an under-

utilization of the Adverse Reactions Advisory Committee. Members of this committee

should be engaged in the promotion of the system nationwide. The fact that only 10% of

the ICSRs were subjected to causality assessment is an indication that the available

expertise is not fully utilized.

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Self-medication of both conventional and traditional medicines is widely practiced in

Ethiopia. The level of harm in the community is not known to authorities unless direct

patient reporting is facilitated and encouraged.

The PV centre is poorly supported by technical facilities. Data management is

fragmented. Relevant information is stored in different systems and moved between

systems. This invites mistakes and is resource demanding and complicates signal

detection. There are no library facilities easy at hand which makes data analysis tedious if

not impossible.

There are questions around the internal quality management; the reliability of keeping

data in different IT-systems, absence of relevant SOPs, the long-term planning of

competence development for staff etc.

Identified signals leading to regulatory actions have mainly concerned product quality

related issues, which probably reflects the inadequate input of clinically serious

consequences of pharmacotherapy reported from the healthcare system, MAH and Public

Health Programmes.

Although plans for communication of patient safety issues developed by EFDA and

communication channels are available, they are not optimally used because of inadequate

resources, both financial and human. Low visibility leads to a poor understanding in the

community of the importance of the system.

Currently, aDSM activities are not supported by supportive supervision visits organized

jointly by EFDA and NTP.

Not all facilities are familiarized with aDSM recording and reporting systems, besides;

there is no clear understanding among reporters regarding which adverse events to report.

No copies of submitted forms are kept at the health facilities, tracking of adverse event

reports is difficult and acknowledgement of receipt is not commonly received by

reporting facility.

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For DR-TB treatment, there is no local database. The ADR reports (yellow forms and/or

line listings, this depends on the availability of internet) are sent to FMHACA through e-

mail and are recorded in an Excel spread sheet used by the PV centre to record all ADR

reports received.

1.3 Alignment of this roadmap with existing national strategic plans

There are existing national plans formulated to strengthen the national Pharmacovigilance

system, some of which are mentioned below.

The national health sector transformation plan (HSTP), which is the current five-years

national health sector strategic plan of the government of Ethiopia, covers the period from

2008-2012 EC (i.e. July 2015–June 2020). One of the strategic objectives of this plan is to

‘Improve the Regulatory System”. Among the many listed, this objective will be achieved

through Pharmacovigilance & post marketing surveillance of products. As part of the HSTP

EFDA has developed health regulatory sector transformation plan (HRSTP) which covers the

year 2015/16-2019/20. The HRSTP has considered an initiative of excelling

Pharmacovigilance system and post market surveillance under the strategic objective of

improving efficiency of health products regulation

In the WHO Global Benchmarking Tool (GBT) for evaluation of National Regulatory System

of medical products, pharmacovigilance is one of the main tools which is incorporated as

institutional development plan (IDP) of the Authority. All the six core indicators namely

Legal provisions, regulations and guidelines required to define regulatory framework of

vigilance, Arrangement for effective organization and good governance, Human resources to

perform vigilance activities, Procedures established and implemented to perform vigilance

activities, Mechanism in place to monitor regulatory performance and output and Mechanism

exists to promote transparency, accountability and communication are in line with and

compatible to this Pharmacovigilance road map.

During the pharmacovigilance roadmap development process, the existing strategic plan

documents were reviewed. The execution period for the activities was discussed with the

respective implementing bodies in order to align the activities with the institutional annual

plans.

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So far, a number of efforts have been made to improve coordination and improve alignment

of strategies to address the health issues in the country. One such intervention is the

formation of a joint steering committee in which managers of all sectors under the MOH

meet for a consultative forum where policies and strategies are debated and consensus built in

leading the health sector. Annual operational plans are set jointly, performances reviewed and

follow-up actions streamlined accordingly in these meetings.

2. Goals and strategic objectives of this roadmapThe over-arching goal of this road map is to achieve the higher level of PV maturity that is

WHO maturity level three. The strategic objectives are:

1) Ensure strong PV Policy, law and regulations

2) Strengthen PV’s systems, structure and stakeholder coordination.

3) Improve Signal generation and data management

4) Improve Risk Assessment and Evaluation

5) Improve risk management and communication practice

3. Methodology and team

3.1. Developing the roadmap

The Ethiopian Food, and drug Authority in collaboration with stakeholders and partners

including AHRI, NTP, KNCV (PAVIA), PROFORMA and AAU developed this road map

towards a strengthened nationalpharmacovigilance system to be implemented from 2019 –

2023. It is prepared based on the findings of a baseline assessment (a situational analysis) of

the various aspects and needs of the PV system in Ethiopia. The findings of the assessment

were discussed with broader stakeholder involvement and the desired development goals of

and interventions for strengthening the PV system were agreed up on which later were used

for development of this road map.

During the pharmacovigilance roadmap development process, the existing strategic plan

documents were reviewed. The document was organized in two major sections. The first

section described the intervention points to address the gaps identified at the national PV

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center and marketing Authorization Holders, while the second section was dedicated for

intervention points on the assessed PHPs (TB, EPI and NTD).

The draft roadmap document was further supplemented by inputs from a wider group of

stakeholders and partners working on Pharmacovigilance. This was obtained through a two

day consultative workshop organized by EFMHACA on March 14 and 15, 2019. The

workshop was attended by 42 participants who were representatives from the national

Pharmacovigilance Center, research Institutes, neglected tropical drugs program, the National

TB Program, WHO- Ethiopia, Regional Health Bureau, Market Authorization Holders,

Professional Association, Healthcare facilities, Non- governmental Partners working on TB,

University/academia, PAVIA project and PROFORMA Project representatives. The

stakeholders were divided into groups as per their expertise and discussed the road map

document. Each group then presented to the plenary the comments and inputs on the

respective sections of the document. After a comprehensive discussion by the plenary on the

forwarded inputs; they were then incorporated in the final roadmap document.

The final roadmap document was presented to the management members of EFDA for

discussions and input was captured and incorporated and finally endorsed by the Director

General of the Ethiopian Food and Drug Authority.

3.2. Relationship between this roadmap and the annual work plans

This roadmap will be accompanied by annual workplans which will be published as separate

documents for every 12 months, detailing the activities to be implemented in the consecutive

periods until the end of the road map implementation. These annual workplans will provide

information about the main organization and focal department responsible for each activity,

contributing partners, detailed timelines, budget needed and funding source, output and

outcome indicators.

Monitoring and Evaluation Tools will be developed by the Authority on how to measure the

established indicators and Final evaluation of the implementation status of this road map will

be carried out accordingly. (Figure 1).

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Figure 1. Monitoring and evaluation framework.

4. Key milestones and activities per strategic areaActivities are listed under the respective strategic areas. The detailed activity plans are

further outlined in table 1.

4.1. Improving the efficiency and functioning of regulatory and organizational structures

Incorporate PV contents into the existing National Drug policy

Re- define the scope and re-structure the PV Unit

Develop a guideline for patient reporting

Develop and introduce a communication and dissemination strategy for routine- and

crisis communication.

Input

• Qualified HR to strengthen the PV Center• Finance to carryout PV activities• Suitable & accommodating office,equipments & technological requirements (includingcomputer,printer, photocopier,internet,telephone, shelfs & Archives etc)

• Reference materials/Hard & Soft copy) related to medicine safety

Process

•Recruit qualified PV staff & ensure regular capacity building on global PV updates• Increase the visibility of PV activities and carry out financial resource mobilization•Re design the PV unit with well furnished and suitable office set up•Provide basic PV training course to health care professionals (HCP)•Distribute PV advocacy and Health education materials for decisission makers and HCPs•Establish library services, Micromedex other reference materials) on medicine safety

Output

• Qualified PV staff Recruited• Adequate finance for PV activities• PV unit with well furnished and suitable office set up• PV training course provided to health care professionals (HCP)• Distribute PV advocacy and Health education materials for decisission makers and HCPs• Establish library services, Micromedex other reference materials) on medicine safety• Training courses given to HCPs• PV Advocacy & Health Education materials distributed in health facilities

Outcome

• Increased awaredness about potential ADRs•Better monitoring for potential ADRs•Increased number of ADE reports• Increased number of signals generated and communicated to MAH and Public HealthProgrammes.and community

Impact•Less medicine-/ADE-related hospitalization

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•Less medicine-/ADE-related hospitalization

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4.2. Improving the financial sustainability of PV activities in the country

Develop and introduce a strategy for improving the longer-term funding base for PV

activities.

Conduct financial resource mobilization for PV activities

Sustainability/exploitation model for PV activities to facilitate mobilization of

financial resources to strengthen capacity and provide better working conditions

4.3. Clarifying the roles and responsibilities for all stakeholders towards ensuring the safety

of medicines

Establish a structural link between the PV Center and public health programmes

(PHPs) – including but not limited to poverty-related diseases (PRD, such as

tuberculosis, HIV, malaria), childhood vaccination and neglected tropical diseases.

Establish standardized procedures for collecting information from PHPs on adverse

drug reactions (ADRs) and sharing this information with the national PV Centre.

Establish standardized procedure for signal detection and signal communication

between PHPs and PV Centres.

Establish collaborative approach in which healthcare professionals, PHPs and national

PV Centres join efforts in collecting, analysing and exchanging information and

sharing expertise.

4.4. Increasing the effectiveness of active (sentinel) surveillance of ADRs

Establish a process for including active surveillance data from PHPs in data used by

regulatory authorities for decision-making on (safety of) newly introduced drug for

PRD.

Perform active surveillance on safety and quality of selected medicines of public

health importance in collaboration with the relevant PHPs (TB , Malaria, HIV, NTD,

NCD ,EPI) and take the necessary regulatory measures

Conduct a quarterly joint supportive Supervision by NTP and National Regulatory

Authority on TICs.

Plan and conduct a refresher /gap filling training for health professionals on selected

medicines of public health importance (TB aDSM, AEFI and NTD) in collaboration

with the relevant PHP drugs

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Provide training for PV/aDSM advisory committee to systematically undertake

causality assessment.

Conduct face to face discussions with health care professionals

4.5. Improving connectivity of databases and (use of) tooling for event detection, reporting,

analysis and dissemination to relevant stakeholder

Develop and introduce a strategy for increasing the number of reports from the

country to international databases by more efficient use of the VigiFlow data

management system

Simplify and adapt currently used tools for AE/AEFI/ADR reporting (e.g. paper

forms or electronic reporting systems for AE reporting by health facilities and

patients; additional reporting options through email, toll-free phone calls, SMS code

system and walk-in) with more user-friendly interfaces

Harmonize these mechanisms with electronic reporting systems for the PHPs.

Optimize the efficiency of the processing of reports in the PV Centre

4.6. Increasing human resources to sufficiently exercise safety-monitoring activities

throughout the country

Establish focal persons in PHP health facilities with high patient loads, and a focal

person in the PV Centre to jointly coordinate PV activities within the PHP.

Create network of healthcare professionals, PV focal persons, DTCs, DICs as means

of alert to safety reporting (e.g., social media group,)

Conduct regular supportive supervision and Progress review workshops regularly.

Community sensitization and promotion using different media outlets (public

campaign, TV/Radio coverage, IEC materials)

Recognizing healthcare facilities and professionals based on their safety reporting

performance

4.7. Improving PV-relevant skills and competencies at various levels

Training plan for existing PV staff, including short course, UG, MSc and PhD

trainings.

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Develop training curriculum for various actors in PV (PV Experts, PV Advisory

committee members, HCP, PHPs, MAH, consumers, Media, community health

workers, etc.); includes web-based training tool development

Provide training on PV to the different stakeholders. (detailed training plan to be

prepared for different stakeholders)

Avail resources (Library services, Micromedex, Drug reference materials) for PV

Centers.

4.8. Gaining experience in monitoring and steering the performance of the PV system

Establish a process for monitoring and evaluating country progress, focusing on

outputs and outcomes (ADR reports received and processed, improvements in active

and passive reporting, reports to international databases) and impacts (signals

detected, revisions of treatment guidelines); analyze barriers (national as well as

overarching); and adapt roadmaps where needed.

Conduct subsequent PV assessments

Prepare and implement PV quality manual (assign PV Quality assurance officer,

monitor for adherence and performance such as feedback)

4.9. Better align with regional and international initiatives to avoid fragmentation of

resources & investments

Engage with e.g. Regional Economic Communities and regional centers of excellence

in PV, NEPAD, the African Medicines Agency, WHO, ISOP and the Uppsala

Monitoring Center

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Table. 1. Activity PlanStrategicobjective

Strategicinitiative

Gapaddressed

Activities Timeline Responsible

partner&person

Outputindicator

Outcomeindicator

Funding

Ensurestrong PV

Policy, lawand

regulations

Ensure that PV

issues

(strengthening

the requirements

for MAH and

Healthcare

facilities) are

well addressed

in relevant

policies

No PV policy

either as

standalone or

subset to other

Incorporate PV

contents into the

existing national

Drug policy

Q4,2020 PV

Center

Policy

Document

prepared

PV Policy

and

guidelines

utilized by

respective

bodies

PAVIA/PROFO

RMA

Revise the national

PV guideline

Q4,2019 PV

Center

Updated

guideline

Patient

reporting

requirements

are not well

addressed

Develop a

guideline for

patient reporting,

Q4,2020

PV center Patient

reporting

guideline

developed

and

familiarized

MAHs are not

required to

Establish a

mandatory

Q4,2019 PV

Center

17

Strategic

objective

Strategicinitiative

Gap

addressed

Activities Timeline Responsi

blepartner&

person

Output

indicator

Outcome

indicator

Funding

keep a position

for

Pharmacovigil

ance (QPPV),

carry out

investigations,

so called Post

Authorization

Safety Studies

(PASS), if

signals have

been received

about possible

problems.

requirement of

QPPV for MAHs MAH

requirement

s stated in

the

Regulation

document

MAH with

QPPV and

post

Authorizati

on Safety

Study

evidence

undertaken

set out timelines for

submission of

PSUR, ISCRs,

RMP in line with

International

Standards,

Q4,2019 PV

Center

Incorporate

Mandatory

performance and

funding of Post

Authorization

Safety Studies

(PASS)

Q2,2019 PV

Center

There are no

specific

Ensure that PV is arequirement forlicensing of HC

Q2,2020 PV center PV

incorporated

certified

HC

WHO

18

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

requirements

for

pharmacovigil

ance systems

in the

licensing of

private

healthcare

facilities.

facilities in Licensing

guidelines

facilities

with well-

established

PV system

Ensure the

establishment of

Branch offices

with relevant

legal

perspectives

No legal

requirements

for

establishment

and

functioning of

branch offices

Incorporate legalrequirements forestablishment andfunctioning ofbranch anduniversityHospitals in theregulation

Q4,2019 PV center Regulation

indicating

legal

mandates

for branch

offices

Branch

offices

with

written

legal

mandates

PAVIA/PRoFOR

MA

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Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

Strengthen

PV’ssystems,

structureand

stakeholdercoordinatio

n.

Establishindependentorganizationalstructure and PVSystem

There are no

detailed Terms

of Reference

(ToR) for the

staff members

employed.

Re- define the

scope and re-

structure the PV

Unit

Q2,2020 EFMHA

CA

Managem

ent

Visibility of

the PV unit

on the

organogram

PV center

with

qualified

and

adequate

staff

members

Staff members

of the PV

centre are too

few to be able

to interact

with, promote

and engage

stakeholders

needed to

ensure input to

Recruit adequate

and qualified

manpower for

executing PS, AS,

AEFI, PHP,

PMS,SFFS, MAH,

drug consumption

data compilation,

Inspection

activities

Q2,2020 EFMHA

CA

Managem

ent

Adequate

staff for the

PV Unit.

20

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

the PV system. Training plan for

existing PV staff,

including short

course, MSc and

PhD training.

End of

project

PV

Center

Training

plan

prepared;

PV staff

trained as

per plan.

PROFORMA

and

PAVIA (for

short courses

Ensure

Adequate and

sustainable

resource base

The ADE

reporting form

is not available

electronically

Develop user

friendly reporting

tool.

Q4,2019 PV

Center

Electronic

reporting

tool

developed

National &

Regional

PV centers

utilizing e-

reporting

and

Vigiflow

WHO

Decentralize

vigiflow to PHP

and Regional

Centers

Q3,2019 PV

Center

Vigiflow

access given

to regional

PV Centers

WHO

21

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

There is no

separate safety

Advisory

committee.

Strengthen and

redefine the scope

of the existing

AEFI committee as

a national PV

Advisory

Committee

Q4,2019 PV

Center

TOR for the

national PV

Advisory

committee.

Number of

causalities

established

with the

support of

the

Committee

PAVIA/PRPFO

RMA

Provide training on

causality

Assessment to the

PV Advisory

committee

Q1,2020 PV

Center

Trained

committee

members

PROFORMA,

WHO, PAVIA

The

pharmacovigil

ance function

does not

benefit from a

Develop and

introduce a strategy

for improving the

longer-term

Q4,2022 PV

Center

Strategy

developed Budget ear

marked for

PV

22

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

designated

annual budget,

which doesn’t

allow it to plan

properly for

sustainability

and long-term

development.

funding base for

PV activities.

activities

Have a specific

budget line for

Pharmacovigilance

on the Authority’s

financial scheme

Q3,2021 EFMHA

CA

Managem

ent

PV

indicated as

a specific

budget line.

Establishinternal qualitymanagement forthe PV system

A draft

Standard

Operating

Procedures

Develop,

familiarize and

avail PV SOPs for

the center

Q4,2019 PV

Center

Narrated list

of relevant

SOPs,

developed

SOPs

PAVIA,

PROFORMA

and WHO

23

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

(SOP) for PV

is available but

not officially

endorsed.

Prepare and

implement PV

quality manual

(assign PV Quality

assurance officer,

monitor for

adherence and

performance such

as feedback…)

Q2,2020 EFMHA

CA

Managem

ent

Quality

manual

developed.

PV system

with IQM

WHO, World

Bank

There is a very

high turn-over

rate of

personnel at

the healthcare

facilities hence

Develop training

curriculum for

various actors in

PV (PV Experts,

PV Advisory

committee

Q4,2019

to Q4,

2020

PV

Center

Training

Curriculum

developed;

Web bases

tool

developed

PAVIA,

PROFORMA

24

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

Build the

Capacity of the

national PV

system

trained HPs

are not

available.

Healthcare

providers at

health

facilities

members, HCP,

PHPs, MAH,

consumers, Media,

community health

workers) ; includes

web based training

tool development

Pool of

trained

professiona

ls on PV

Trainings are

not given to

community

health

workers.

Provide training to

the different

stakeholders.

(detailed training

plan to be prepared

for different

stakeholders)

Q3,2019-

2023

PV

Center

Training

Plan

developed

PAVIA/PROFO

RMA

25

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

EFDA does

not have

access to any

library service

Avail resources

(Library services,

Micromedex, Drug

reference materials)

for PV Centers

Q4,2019 PV

Center

Reference

materials

availed at

the centers

Utilization

rate of

Library

and quality

of

reference

materials

PAVIA

Create effective

stakeholder

coordination

system

PoorcoordinationbetweenEFMHACAand PHP inharmonizationofimplementation of PV

Establish a national

platform for

coordination of PV

Activities among

stakeholders and

ensure the

functionality

(MOU, TOR)

Q1,2020 PV

Center

National

Platform

established

by

TOR/MOU

Number of

coordinatio

n events

conducted

PAVIA/PROFO

RMA

26

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

Mark annual PV

day

Q1,2020 PV

Center

PV day

celebrated

PAVIA/PROFO

RMA

There are

minimal

number, type

and quality of

safety reports

Create network of

healthcare

professionals, PV

focal persons,

DTCs, DICs as

means of alert to

safety reporting

(e.g social media

group,…)

Q3,2019 PV

Center

Network

created

Increased

Establish regional

Pharmacovigilance

centers

Q4,2019 PV

Center

Established

six Regional

PV Centers

WHO

Conduct regular

supportive

supervision and

Q4,2019 PV

Center

Supervision

conducted;

review EFDA

27

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

Improve

Signalgeneration

& datamanageme

nt

Optimize ADEreporting andsignalgenerationefforts

received by the

PV center

Progress review

workshops bi-

annually.

workshop

conducted

number ofreports to5,000 andreports peryearCommunity

sensitization and

promotion using

different media

outlets (public

campaign,

TV/Radio

coverage, IEC

materials)

Q3,2019

(four

sensitizat

ion

events

per year)

PV

Center

Four

community

sensitization

events

conducted

per year

Recognizing

healthcare facilities

and professionals

based on their

safety reporting

Annually PV

Center

Appreciatio

n

Certificates

awarded to

reporters

28

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

performance based on

performance

ImproveRisk

Assessmentand

Evaluation

Perform risk

assessment and

evaluate

risk/benefit ratio

based on

investigations of

available

national/internat

ional

Limited

records on

causality

Assessment

(Only 10

reports were

subjected to a

formal

causality

assessment

during the past

calendar

year,2010EC)

Carry out analysis

on safety data

obtained from

passive

surveillance/sponta

neous reporting and

take the necessary

regulatory

measures

Starting

Q2,2019,

Continuo

us

PV

Center

Reports

analyzed;

regulatory

measures

taken

Improve

the number

of causality

Assessmen

ts

conducted

and signals

detected

Conduct Post-

Marketing

Limited

number of

Perform active

surveillance on

Starting

from

PV

Center,

Ongoing

active

PROFORM,

PAVIA, Global

29

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

Active

Surveillance of

medicines

active cohort

study initiated

by the

regulatory

safety and quality

of selected

medicines and

vaccines of public

health importance

(TB, Malaria, HIV,

NTD, NCD, HPV)

and take the

necessary

regulatory

measures

Q4,2019 AHRI surveillance

s

fund, WHO

Ensure the

availability and

implementation

of Risk

Management

and

There is no

record of PV

plan by MAH

as required by

FMHACA

Archive records of

RMP and

communication

plan for all

marketed products

by MAH

Q2,2020 PV

Center

Archived

RMPs and

communicat

ion plan

30

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

Improveriskmanagemen

communication

plan

Public

Questions

received by the

toll-free line

are neither

forwarded to

nor recorded

by the PV

Center.

Develop risk

communication

strategy for the

national PV center

to communicate

with key

stakeholders in the

PV network

nationally and

internationally

Q4,2019

Risk

communicat

ion strategy

developed

The

number of

risks

communica

ted

PAVIA,

WHO

31

Strategic

objective

Strategicinitiative

Gap

addressed


blepartner&

person

Output

indicator

Outcome

indicator

Funding

t andcommunication practice

Thereis no

communicatio

n records

related to

medicine

safety that

have been

targeted

towards the

general public

Develop/ adopt

communication

plan for PV

activities

Q1,2020 PV

Center

Communica

tion plan

developed

PAVIA

32

Activities regarding aDSM

Specificobjective

Gap addressed Activities Timelines Responsiblepartner &person

Outputindicator

Outcomeindicator

Funding

Establish /

strengthen TB

aDSM

coordination

mechanism

There is no functional

TB aDSM coordinating

committee.

Establish/revitalize anational TB aDSMcoordinating team (NTP,FMHACA, Otherstakeholders) with definedTOR

Q3,2019 PV Center,NTP

Signed TOR

Functional TBaDSMcoordinationmechanisms

Improvednumber ofsafety reportsand TB aDSMdata

PAVIA

No coordination betweenthe national PV advisorycommittee and the TBClinical ReviewCommittee.

Update the respectiveTORs and indicate clearresponsibilities of the CRCand National PV AdvisoryCommittee

Q3,2019 PV Center,NTP

Signed TORs

There is no clearunderstanding amongreporters regardingwhich adverse events toreport.

Develop SOP to indicatethe reporting flow andwhich adverse events toreport for TB aDSM

Q4,2019 PV Center,

NTP

SOP/ guidedeveloped

33

Specificobjective


Outputindicator

Outcomeindicator

Funding

Promote

existing ADE

reporting tools

for capturing

aDSM data

No copies of submittedforms are kept at thehealth facilities, trackingof adverse event reportsis difficult andacknowledgement ofreceipt is not commonlyreceived at by reportingfacility

Promote electronic andMedsafety app ADEreporting systemforrecording and reportingaDSM data

Q4/2019 NTP Number ofaDSM datacaptured withMedsafetyapp&Electronicreporting tool

WHO

Strengthen the

capacity of

health care

providers on

safety

reporting and

TB aDSM

Supportive supervisions

are not conducted by

NTP and EFDA.

Conduct a quarterly jointsupportive Supervision byNTP and EFMHACA onTICs.

Starting

Q2,2019

PV center,NTP, AHRI

Supportive

Supervision

checklist

developed,

conducted,

Action plandeveloped

Improved

number of

safety reports

and TB aDSM

data

PAVIA

Not all facilities are

familiarized with

aDSMrecording and

reporting systems

Plan and conduct arefresher /gap fillingtraining for healthprofessionals on TB aDSM

Starting

Q4,2019

PV center,NTP

Training plan

developed;

training

provided

Assure that PV/aDSM advisory Provide training for Q1, 2020 NTP, PV Trained PAVIA,

34

Specificobjective


Outputindicator

Outcomeindicator

Funding

causalityassessment isconducted asper therequiredstandards

committee is not

formally trained on

causality assessment

PV/aDSM advisorycommittee tosystematically undertakecausality assessment

center committeemembers

Improvednumber ofCausalitiesestablished

WHOPAVIA,WHO

Ensure that

safety

information is

timely

communicated

to the public

and healthcare

providers.

Safety issue is notincorporated in routineclinical mentoring andcohort analysis.

Incorporate safety issues inroutine clinical mentoringand cohort analysis.

StartingQ4,2019

NTP

Safety issuesaddressed inroutinepractices

Number ofsafeycommunications related toMDR TB drugs

AE information is notroutinely featured in anyform available at theNTP

Incorporate special issue ofTB aDSM on quarterly PVnewsletter

StartingQ3,2019

NTP, PVCenter

aDSM sectionincluded inthe newsletter

Organize a session on a

regular basis and present

summaries on TB aDSM at

DTCs of TICs

Starting

Q3,2019

NTP, PVCenter

aDSMsummariespresented toTICs

35

Activities Regarding EPI and NTD ProgramStrategic

ObjectivesStrategicInitiatives

GapAddressed

Activities Timeline Responsible Partner

OutputIndicator

OutcomeIndicator

Funding

Creating anational

PV/EPI/NTDcoordination

plat form

Establish anIndependentandfunctionalnational PVcoordinatingbody

The AEFIguideline andthe 2016 –2020EPIcomprehensiveplans are notbeingimplementedproperly.

Establish anationalPV platformforcoordinationof PVActivitiesamongstakeholders(DevelopMOU/TOR,and SOP)

2020 EFDA/MoH/

Developingpartners

Platformcreated andsupportivedocumentsdeveloped

FunctionalNational PV

platform

EFDA/PROFORMA

Strengthenmonitoringmechanismand tool for

PV activities atEPI and NTD

programs

Poorcoordination

between EFDAand PHP in

harmonizationof planning,

implementationand monitoringand evaluationof PV activities

ImplementingregularPV-programreviewmeetings &supportivesupervision atnational &regional levelin

Continuous

EFDA/MoH/

Developingpartners

Assignedreviewmeeting forPVPV indicatedin SSchecklist

Number ofReview

meeting andsupportivesupervision

36

StrategicObjectives

StrategicInitiatives

GapAddressed


OutputIndicator

OutcomeIndicator

Funding

collaboration

StrengtheningPV activitiesat EPI and

NTD program

Establishseparate PV-TWG forcoordinatingPV activities

The NTDmaster plan andthe EPI-comprehensiveplan lack detailson PV

Establishseparate PV-TWG atnational andregional levelwith clearroles andresponsibility

2020 EFDA/MoH/

Developingpartners

EstablishedTWG

PV activitiesimplemented

at EPI andNTD

program

Build theCapacity ofHealthcare

workersworking at

EPI and NTDprogram at all

level

Developnationalstandardtrainingpackages forPV

PV trainingsgiventoHCPs andthecommunityworkerslacks detailsonAEFI/ADE

Developtrainingcurriculumforhealthcareworkers

2020 EFDA/MoH/

Developingpartners

TrainingCurriculumdeveloped

Pool oftrained HCP

EFDA/PROFORMA

No nationalstandard-PVtrainingpackages

Preparenational PVstandard“Trainer guideand Participantmanual”HCP working

2020 EFDA/MoH/

Developingpartners

TrainingPackage

developed

Pool oftrained HCP

EFDA/PROFORMA

37

StrategicObjectives

StrategicInitiatives

GapAddressed


OutputIndicator

OutcomeIndicator

Funding

on EPI andNTD program

Improve RiskAssessment

andEvaluation

ConductPost-MarketingActiveSurveillanceof EPI/NTDmedicines

No activesurveillancestudies havebeen carriedout on EPIand NTDmedicines

Perform Postmarketingactivesurveillance onthe safety andefficacy ofselectedmedicines

2021-2023

EFDA/MoH/

Developingpartners

Ongoingactive

surveillance

Surveillanceresult

EFDA/PROFORMA

Improve Riskmanagement

andCommunicati

on

Ensure thatsafetyinformationrelated toEPI andNTDs aretimelycommunicated to thepublic andhealthcareproviders

The existinginformationcommunications to thepublic andhealthcareprofessionalsdoesn’t targetPV

Develop PVcommunication strategyand materials

Incorporatespecial issueEPI and NTDon quarterlyPVnewsletter.

Startingfrom2020

EFDA/MoH/

Developingpartners

DevelopedPV

communication strategy

and material

EPI and NTDsection

included inthe

newsletter

Number ofrisks

communicated

EFDA

38

5. Conclusion

Guided by this roadmap, the national pharmacovigilance center will strive for establishing

PV quality management systems and improvement in the number of reports collected to

5,000 reports per year with the aim of making the PV Center regional center of excellence

and finally achieve the higher level of PV maturity that is WHO maturity level three.

The roadmap is not intended to cover every possible area, nor can it accurately predict the

changes that will occur in the Pharmacovigilance theme. The roadmap is set out for a period

of five years in order to fill the gaps identified through the baseline situational analysis on the

national Pharmacovigilance system. During this time period, additional activities may be

identified as part of the Authority’s ongoing strategic thinking especially in the process of

performance reviews and developing annual plan.

This roadmap was developed as a product of the PAVIA project 2 and PROFORMA3, which

is part of the EDCTP2 programme supported by the European Union (grant number

CSA2016S-1627-PAVIA).

39

1PAVIA (Pharmacovigilance Africa) envisions to strengthen the PV systems in four countries: Ethiopia, Nigeria, Eswatini and Tanzania,to have more effective drug safety reporting mechanisms for new products introduced and to gain a better understanding of their safetyprofiles. PAVIA’s objectives are:

1. To strengthen governance of Pharmacovigilance (PV) systems, by strengthening regulatory and organizational structures anddefining clear roles and responsibilities for all stakeholders

2. To improve efficiency and effectiveness of national surveillance systems, by strengthening active (sentinel) surveillance ofadverse drug reactions and implementation of tools and technologies for their detection, reporting, analysis and dissemination

3. To build capacity and skills to sufficiently conduct safety-monitoring activities throughout the country4. To improve readiness of health systems within Sub-Saharan Africa by improving performance assessment of PV systems

allowing identification of enablers and barriers for implementation.PAVIA’s strategy is to strengthen national PV systems in a collaborative effort with Public Health Programs (PHPs), building up medicinessafety surveillance activities in the context of the introduction of new drugs for multidrug-resistant tuberculosis. Capacity at the national PVCentre/national medicines regulatory authority will be built gradually taking the PV activities for tuberculosis as the “building and trainingground” for a generic PV system including data collection, database entry, data analysis, signal identification and causality assessment. Theresults and lessons learned will be transferred by PAVIA to the PHP for HIV and malaria. Combined with identified enablers and barriers inaddressing regional differences and needs, a blueprint will be developed that can guide other countries in strengthening their PV systems.

2PROFORMA PhaRmacOvigilance infrastructure and post-marketing surveillance system capacity building FOR regionalMedicine regulatory harmonization in East Africa. PROFORMA aim is to strengthen the national pharmacovigilanceinfrastructure and post-marketing surveillance system in four east African countries Ethiopia, Kenya, Tanzania, and Rwanda. Thegoal of PROFORMA is to establish/strengthen sustainable pharmacovigilance system in East Africa that is aligned with the large-scaleAfrican medicine regulatory harmonization and WHO’s Pharmacovigilance programme. The objectives of PROFORMA are

1. To strengthen the national pharmacovigilance infrastructure and post-marketing surveillance systems, and regulatorycapacity,

2. To strengthen Pharmacovigilance/monitoring of medicines safety in mass drug administration and immunizationprograms to monitor the public safety

3. To establish a triangular collaboration between Academia, national medicine regulatory Authorities and public healthprograms to strength the capacity of safety monitoring through collaboration in capacity building traning and researchfor evidence based decision.

Based on the baseline assessment the main regulatory functions that need capacity building will be identified and prioritized. PROFORMAaims to generate a cohort of pharmacovigilance trained human resources from all stockholders including patients, healthcare providers,regulatory staffs that are engaged in pharmacovigilance data collection, analysis, interpretation and data sharing. Emphasis will be given toimplement active drug safety surveillance in clinical trials regulation and post-marketing surveillance in public health programmes involvingmass drug administration and immunization programmes. A total of 12 postgraduates (4 PhDs + 8 MSc) will be trained to serves as part ofthe future PV expert regional task force.

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